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Tuesday, November 15, 2005

return to Comstock?

No offense to our student newspaper, but it’s a sad day when the Crimson bests the FDA at making factually-based recommendations about contraception.

The final three paragraphs of today's NYT article on the FDA scandal surrounding Plan B reveal the downright sketchiness of the agency's conduct:
In his rejection letter to Barr, Dr. Galson suggested two ways it could receive approval. First, it could perform another study that included more young adolescents. Or it could seek to sell the drug "behind-the-counter," making it easily available only to women 16 and older, with younger women still needing a prescription.

Barr took the second approach in an application filed in July 2004. Although the agency's rules required it to issue a decision in January, it has delayed doing so indefinitely.

It is unusual for the agency to suggest a means of approval to an applicant only to decide later that its own suggestion might not be appropriate.
The indefinite delay isn't the end of the story, either. (more in expanded post)

In August of this year, the FDA announced that since the Plan B over-the-counter (OTC) application raises (supposedly) new and profound questions about the function of the agency (namely, whether it should be able to approve simultaneous prescription-only and OTC status to the same drug with age being the sole factor determining access), the FDA would ask the public to weigh in. Among the various groups that have responded so far, the American Society for Reproductive Medicine had this to say, and the Association of American Physicians offered an opposing opinion. The most comprehensive expert analyses I've been able to find so far are from the New England Journal of Medicine (check out the article by Steinbrook).

One of the more compelling arguments I've come across: if children are able to purchase drugs like aspirin, which can be deadly if used improperly, why the special concern that girls under 16 will abuse emergency contraception? From Steinberg's opinion piece in the NEJM:
The FDA has never required specific data on the safe and correct use of these or other medications in children and adolescents, although their improper use is harmful and potentially lethal. When asked in a conference telephone call with reporters about the effect of the decision, Galson said that every review is different and "requires a separate kind of risk–benefit assessment." He added, "I wouldn't think it is accurate to predict what we are going to do with future products based on what we are doing now."
Gee, that's funny: I thought precedent was kind of important in governmental decisionmaking...

In closing, a little history: The Comstock Act of 1873 criminalized trade and/or public distribution of "obscene, lewd, lascivious, indecently filthy, or vile" information and materials, including those related to contraception and abortion. The government overstepped its bounds in attempting to legislate morality, and women's access to contraception (as well as their general reproductive freedom) decreased as a result. Today, while the FDA couches its argument against Plan B in terms of safety rather than decency, the resignations of two of its own officials attest to at least some moral/political motivation to these shenanigans, and the outcome is the same: unfair restriction of women' s ability to control their own fertility.


At 8:55 PM, Anonymous Anonymous said...

isn't it just a little sad when the Crimson is giving us contraception recommendations at all???


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